drug facts

drug facts
SPL v1
SPL
SPL Set ID 7a8127c4-37ab-4eb5-9279-da83101bceeb
Route
topical
Published
Effective Date 2018-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (20 mg)
Inactive Ingredients
water sodium c14-16 olefin sulfonate glycerin cocamidopropyl betaine carbomer copolymer type a (allyl pentaerythritol crosslinked) sodium chloride hydrogenated castor oil carrageenan c12-15 alkyl lactate edetate sodium cocamidopropyl pg-dimonium chloride phosphate pummelo polyquaternium-7 (70/30 acrylamide/dadmac; 1600000 mw) green tea leaf ascorbyl palmitate neopentyl glycol dicaprylate/dicaprate chamaemelum nobile flower polysorbate 20 polyvinyl alcohol (100000 mw) propylene glycol butylene glycol sodium benzotriazolyl butylphenol sulfonate agar sodium hydroxide mica titanium dioxide d&c red no. 33 fd&c red no. 40 ext. d&c violet no. 2

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2018-06-20
Purpose

Acne Treatment

Description

Salicylic Acid 2%

Medication Information

Warnings

For external use only.

Uses
  • For the treatment of acne.
Purpose

Acne Treatment

Directions
  • Use daily in the shower or bath. Gently massage on wet skin with washcloth or body puff, concentrating on areas prone to breakouts. Rinse thoroughly.
Other Information
  • store between 20°C - 25°C (68°F - 77°F)
Inactive Ingredients

Water (Aqua), Sodium C14-16 Olefin Sulfonate, Glycerin, Cocamidopropyl Betaine, Acrylates Copolymer, Sodium Chloride, Hydrogenated Castor Oil, Carrageenan, C12-15 Alkyl Lactate, Disodium EDTA, Cocamidopropyl PG-Dimonium Chloride Phosphate, Citrus Grandis (Grapefruit) Fruit Extract, Polyquaternium-7, Camellia Sinensis Leaf Extract, Ascorbyl Palmitate, Neopentyl Glycol Dicaprylate/Dicaprate, Anthemis Nobilis Flower Extract, Polysorbate 20, Polyvinyl Alcohol, Propylene Glycol, Butylene Glycol, Sodium Benzotriazolyl Butylphenol Sulfonate, Agar, Sodium Hydroxide, Mica, Titanium Dioxide (CI 77891), Red 30 (CI 73360), Red 40 (CI 16035), Ext. Violet 2 (CI 60730), Fragrance (Parfum).

Description

Salicylic Acid 2%

Label Copy

Active Ingredient

Salicylic Acid 2%

Questions/comments?

1-800-925-4733

When Using This Product
  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Keep Out of Reach of Children.
  • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Stop Using This Product and Ask A Doctor If
  • irritation or redness develops and lasts.
Ask A Doctor of Pharmacist Before Use If You Are
  • using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless otherwise directed by a doctor.

Structured Label Content

Warnings

For external use only.

Uses
  • For the treatment of acne.
Purpose

Acne Treatment

Directions
  • Use daily in the shower or bath. Gently massage on wet skin with washcloth or body puff, concentrating on areas prone to breakouts. Rinse thoroughly.
Other Information (Other information)
  • store between 20°C - 25°C (68°F - 77°F)
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Sodium C14-16 Olefin Sulfonate, Glycerin, Cocamidopropyl Betaine, Acrylates Copolymer, Sodium Chloride, Hydrogenated Castor Oil, Carrageenan, C12-15 Alkyl Lactate, Disodium EDTA, Cocamidopropyl PG-Dimonium Chloride Phosphate, Citrus Grandis (Grapefruit) Fruit Extract, Polyquaternium-7, Camellia Sinensis Leaf Extract, Ascorbyl Palmitate, Neopentyl Glycol Dicaprylate/Dicaprate, Anthemis Nobilis Flower Extract, Polysorbate 20, Polyvinyl Alcohol, Propylene Glycol, Butylene Glycol, Sodium Benzotriazolyl Butylphenol Sulfonate, Agar, Sodium Hydroxide, Mica, Titanium Dioxide (CI 77891), Red 30 (CI 73360), Red 40 (CI 16035), Ext. Violet 2 (CI 60730), Fragrance (Parfum).

Label Copy

Active Ingredient (Active ingredient)

Salicylic Acid 2%

Questions/comments?

1-800-925-4733

When Using This Product (When using this product)
  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Keep Out of Reach of Children. (Keep out of reach of children.)
  • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Stop Using This Product and Ask A Doctor If (Stop using this product and ask a doctor if)
  • irritation or redness develops and lasts.
Ask A Doctor of Pharmacist Before Use If You Are (Ask a doctor of pharmacist before use if you are)
  • using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless otherwise directed by a doctor.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:35.457297 · Updated: 2026-03-14T22:55:09.496341